Hypercholesterolemia
Conditions
Brief summary
Primary Objective: Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727). Secondary Objectives: * Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function. * Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with hepatic impairment and in matched subjects with normal hepatic function.
Detailed description
Total duration of the study per subject (excluding screening) is about 12 weeks.
Interventions
alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9) Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
: * Male or female, between 18 to 75 years of age, inclusive. * Patients with mild and moderate hepatic impairment based on Child-Pugh score and stable chronic liver disease. * Healthy subjects with normal hepatic function.
Exclusion criteria
* Patients with acute hepatitis, hepatic encephalopathy grade 2, 3, and 4. * Patients with history or presence of uncontrolled clinically relevant illness. * Healthy subjects with history or presence of clinically relevant illness. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727) | Up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of PK parameter - apparent total body clearance (CL/F) | Up to 12 weeks |
| Assessment of PK parameter - Distribution volume at the steady-state (Vss/F) | Up to 12 weeks |
| Assessment of PK parameter - time to maximum concentration (tmax) | Up to 12 weeks |
| Assessment of PK parameter - terminal elimination half-life (t1/2z) [ | Up to 12 weeks |
| Pharmacodynamics: Change in LDL-C from baseline | Up to 12 weeks |
| Number of participants with Adverse Events | Up to 12 weeks |
| Assessment of PK parameter - Mean Residence Time (MRT [area]) | Up to 12 weeks |
Countries
France, Moldova
Outcome results
None listed